annual report 07

two decades of innovating new therapies and creating new opportunities to make a difference

1987  |  1990s  |  2000  |  2001  |  2002  |  2003  |  2004  |  2005  |  2006  |  2007

1987

August 24, 1987 — Cephalon is founded.

1991

Initial Public Offering (IPO) raises $54.4 million to support the Company’s ambitious plan to build an integrated biopharmaceutical company.

1993

Cephalon initiates clinical trials in the U.S. and files an Investigational New Drug (IND) application for modafinil for the treatment of excessive daytime sleepiness associated with narcolepsy.

The Company establishes a European presence in the United Kingdom (U.K.) and Ireland.

1994

The Company initiates a collaboration with TAP Pharmaceuticals to explore the use of the Company’s proprietary multilineage kinase inhibitors in the field of oncology.

1998

The Company’s first product, PROVIGIL® (modafinil) Tablets [C-IV], is approved in the U.S. and the U.K. It is the first new medication approved for narcolepsy in 40 years.

1999

Cephalon launches PROVIGIL, the first in a new class of wake-promoting agents, in the U.S.

 

 

2000

Cephalon acquires its first pain product, ACTIQ® (oral transmucosal fentanyl citrate) [C-II], and relaunches the product in the U.S.

ACTIQ is the first medication in the world approved for treating breakthrough pain in opioid-tolerant cancer patients.

Cephalon acquires U.S. product rights to GABITRIL® (tiagabine hydrochloride), a unique anti-seizure therapy and the first and only selective GABA reuptake inhibitor approved by the U.S. Food and Drug Administration (FDA).

2001

Cephalon receives authorization to market ACTIQ in 16 European countries.

The Company’s presence in Europe is dramatically expanded through the acquisition of the French pharmaceutical company Laboratoires L. Lafon and its largest selling product, the anti-spasmodic drug, SPASFON® (phloroglucinol).

2002

Cephalon acquires the international rights to GABITRIL.

2003

The U.S. FDA approves a new compressed powder formulation of ACTIQ and the transfer of manufacturing of this product to the Company’s newly expanded facility in Utah.

2004

PROVIGIL is approved for additional indications by the U.S. FDA to improve wakefulness in adult patients with excessive sleepiness (ES) associated with shift work sleep disorder (SWSD) and treated obstructive sleep apnea (OSA).

The Company acquires CIMA LABS INC., a Minnesota-based drug delivery company with the first tablet formulation of the opioid fentanyl in development.

Cephalon revenues exceed $1 billion for the first time.

2005

Cephalon acquires TREANDA® (bendamustine HCI) for Injection, an oncology-targeted candidate in development for the treatment of hematologic malignancies, such as leukemia, lymphoma and myeloma.

The Company acquires TRISENOX® (arsenic trioxide) injection, a product approved in both the U.S. and Europe for treatment of relapsed or refractory acute promyelocytic leukemia (APL), a life-threatening hematologic cancer. The acquisition includes a dedicated hematology sales force in the U.S. and specialized oncology medical representatives in Europe.

Cephalon accelerates its entry into the European oncology market with the acquisition of Zeneus Holdings Ltd. The acquisition adds a direct presence in 19 countries in Europe and an oncology portfolio that includes MYOCET,® a liposomal formulation of doxorubicin for the treatment of metastatic breast cancer.

The Company enters a partnership with Alkermes to commercialize VIVITROL® (naltrexone for extended-release injectable suspension), a novel treatment for alcohol dependence, that expands the Company into a new therapeutic area.

2006

The U.S. FDA approves VIVITROL, the first, once-monthly injectable medication for alcohol dependence.

The U.S. FDA approves the Company’s second unique formulation of the opioid fentanyl, FENTORA® (fentanyl buccal tablet) [C-II].

2007

Cephalon files a marketing application with the European Agency for the Evaluation of Medicinal Products (EMEA) for its fentanyl buccal tablet formulation, under the trade name EFFENTORA,™ in Europe.

The U.S. FDA approves NUVIGIL™ (armodafinil) Tablets [C-IV] to improve wakefulness in patients with excessive sleepiness associated with treated OSA, narcolepsy and SWSD.

Additional clinical work initiated to explore the potential of NUVIGIL in a wide range of medical disorders.

Cephalon acquires the North American rights to AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), a U.S. FDA-approved once-daily extended-release muscle relaxant.

Cephalon submits a supplemental New Drug Application (sNDA) to the U.S. FDA seeking approval to market FENTORA for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions other than cancer.

The U.S. FDA grants Orphan Drug Designation and priority review status to the New Drug Application (NDA) filing for TREANDA, an investigational treatment for chronic lymphocytic leukemia (CLL).

Cephalon files an NDA for TREANDA for treatment of patients with indolent (or slow growing) non-Hodgkin’s lymphoma (NHL) who have progressed during or following rituximab treatment.

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